A Phase IIb 3 Arm Randomized Clinical Pilot Study to Assess the Impact of a Peer-support Program to Improve Social Isolation and Loneliness Due to COVID-19 - Comparing the Addition of a Secure, User Friendly Video-conference Solution and Telephone Support Alone to a Waiting List Control Group
试验速览
- 阶段
- 不适用
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Change in De Jong Gierveld Loneliness Scale at Baseline
研究概览
简要总结
Social isolation and loneliness worsen older peoples' quality of life, risk of dementia, and contributes to 45,000 deaths/year in Canada - as much as smoking. Isolated people use the health care system more often, but have worse outcomes. Effective, inexpensive interventions exist but unfortunately they have not been implemented in Canada.
We partnered with the Australian developer of HOW R U?, an effective and feasible intervention that uses specially trained, older, hospital volunteers to provide peer support to combat isolation and loneliness in isolated older peers.
Little is known about older people's preferences for virtual care (telephone vs. video) nor their relative effectiveness. Thus we will compare two ways of delivering HOW R U: telephone support and a tested, secure user-friendly video conferencing app, aTouch Away® to a common control arm.
We also partnered with Emergency Medicine, Family Medicine, Geriatrics and Psychiatry to identify people who will benefit from peer support; and with Volunteer Services to recruit volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
We will use intention-to-treat analysis for the primary outcome to further protect against selection bias. It is not feasible to blind participants to the intervention. Primary outcomes will be assessed after 12 weeks by a research assistant who has had no previous contact with participants and is blinded to the intervention group.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any community-dwelling person 70 years of age and older receiving care from the ED, Family Medicine, or Geriatric clinics at our two participating sites (MSH and NYGH) will be eligible.
排除标准
- •age less than 70 years; communication problems (critically ill, unconscious, language barrier, speech impairment or otherwise unable to provide consent), or admission to a hospital for > 72 hours. Patients with severe cognitive impairment or those living in nursing homes who are dependent on others for their activity of daily living will be excluded. To target the intervention for older people with loneliness a baseline de Jonge loneliness scores of 2.0 will be required for participation in the trial.
研究组 & 干预措施
Wait-list Control Group
Control groups will be offered standard care through their referring service (i.e. their routine clinical follow-up). The control group will be offered HOW RU? telephone support outside of the main trial after their primary outcome assessment at 12 weeks
HOW RU Intervention delivered by telephone
Group Phone will receive the HOW RU? intervention over the telephone.
干预措施: HOW R U? Intervention (Other)
HOW RU Intervention delivered by video-call
Group Video will receive the HOW RU? intervention delivered over video-call using the aTouch Away platform.
干预措施: HOW R U? Intervention (Other)
结局指标
主要结局
Change in De Jong Gierveld Loneliness Scale at Baseline
时间窗: This scale will be collected at baseline and at 12 weeks.
We will use the 6-item De Jong Gierveld loneliness scale as our primary outcome measure.The minimum value is 0 and the maximum value is 6.
次要结局
- Change in Social Network(Baseline and at 12 weeks)
- Change in Mood(Baseline and at 12 weeks)
- Change in Quality of life(Baseline and at 12 weeks)
- all-cause mortality(Follow-up phone call at 12 weeks)